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IRCT20120718010324N84 IRCT 2025-08-23 Tabriz University of Medical Sciences Investigating the impact of continuous midwifery care on socially vulnerable women Implementation and evaluation of the effectiveness of the continuous midwifery care model in socially vulnerable women: a randomized controlled clinical trial 2025-09-11 anticipated 92 Complete https://irct.ir/trial/85429 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A study will be conducted on 92 pregnant women identified as vulnerable (experiencing violence, living in poverty, or having an unplanned pregnancy), with 46 participants in each group, beginning from gestational weeks 12 to 14. Eligible participants will be selected for inclusion in the present study. Sampling will be performed using a simple random method based on a random number table. Comprehensive information regarding the research, its objectives, and implementation procedures will be provided to the women. Those who express willingness to participate will complete the following questionnaires: the World Health Organization's Domestic Violence Questionnaire, the Socio-Economic Status (SES) assessment, and forms collecting individual, social, and obstetric information. Subsequently, participants who, based on the aforementioned questionnaires, have experienced physical or sexual violence, fall within the poor or poorest categories according to the wealth index, or report an unplanned pregnancy, will be asked to provide written informed consent. These individuals will then be randomly assigned to the study groups. For the allocation of participants into intervention and control groups, a simple block randomization method will be employed, using block sizes of 4 and 6 and an allocation ratio of 1:1. Stratification will be based on parity status (primiparous vs. multiparous). To ensure allocation concealment, the type of intervention will be written on paper and placed inside opaque, consecutively numbered envelopes. These envelopes will be opened in the order of participants’ entry into the study, thereby determining their group assignment, Blinding description: Due to the nature of this study, blinding of participants or the intervention provider is not feasible. However, the outcome assessor and data analyst will remain blinded. Outcome evaluation will be conducted by a research assistant. Regarding data analysis, participants will be coded in such a way that the analyst will not have access to information indicating group allocation. This approach ensures that data analysis and interpretation remain unbiased. N/A Maternal care and high-risk pregnancies. Intervention 1: Intervention group: Participants in the intervention group will receive continuous midwifery care from the 14th week of pregnancy until 6 weeks after delivery by a permanent midwife (researcher). In addition to routine prenatal and postpartum services, this care will include continuous and individualized care in three stages: antenatal (pregnancy), labor, and postpartum. In the prenatal stage, obstetric care will include continuous visits, group education, assessment of the mother's clinical condition, and continuous response to women's physical and psychological needs. For this purpose, six group sessions will be held during pregnancy at intervals of (14-16 weeks, 18-20 weeks, 22-24 weeks, 26-30 weeks, 32-34 weeks, and 36-38 weeks) in health centers in Bonab city. In the postpartum phase, two counseling and education sessions will be held in the health centers of Bonab city within 3 to 5 days and 4 to 6 weeks after delivery. Each group session will be held for 2 hours with the presence of 2 to 10 women and will be facilitated by a researcher (midwifery doctoral student). The content of each session will be based on the educational curriculum of the World Health Organization (WHO), the International Confederation of Midwives (ICM), the national guide to providing midwifery and childbirth services, and the content of the Midwifery continuous care model. The opinions of experts (perinatologists, reproductive health specialists, and midwives) will be used to confirm the content of the sessions. The duration of training in each session will be 60 minutes on predetermined topics focused on the patient's needs and related to the content, and 30 minutes will be allocated to measuring vital signs, listening to the fetal heartbeat, checking the height of the uterus and the weight of the pregnant mother, and the remaining 30 minutes of each session will be allocated to group discussion on possible questions and problems of the mothers. Also, a group will be formed on the social network that the mothers have the most convenient and most access to (such as ETA or WhatsApp, etc.), and the meeting materials will be uploaded there in a completely simple and understandable language, as well as additional materials, and the group members will also have the opportunity to ask questions and answer questions, and the research midwife will be available to the mothers at any time. The control group will receive standard care according to national guidelines. Participants in the intervention group will be encouraged not to visit the hospital before the onset of real pain (even before the start of the active phase of labor, if possible) to minimize unnecessary intervention, and participants will also be emphasized to inform the researcher when they visit and are hospitalized for delivery. For participants in the intervention group, the researcher will be present at their bedside in the labor ward and will support and encourage them throughout all stages of labor (this support includes providing a calm and stress-free environment, psychological and emotional support, and the active presence of the midwife to guide the mother by teaching breathing and relaxation techniques, encouraging the mother to focus on her abilities, reducing anxiety and boosting self-confidence, and helping to do appropriate exercises such as waist movements, kicking mud, and climbing stairs). The mother will be delivered by the researcher's midwife. She will also accompany the mothers in starting breastfeeding for the first 2 hours after delivery to support this stage. If mothers are hospitalized prematurely, the researcher will meet with the mothers in person at least once a day to check on their condition. Participants in both groups will be followed up for up to 6 weeks postpartum, and the final two counseling and education sessions will be held 3-5 days and 4-6 weeks postpartum. Intervention 2: Control group: The control group will receive standard care according to national guidelines. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of participants' information
public Fatemeh Ahadi- yulghunlu
Chaharborj, Imam Ave, Shahid Shokrani Alley, next to the clinic
Chaharborj Iran (Islamic Republic of) 5977183808 +98 914 496 5317 fatemehahadi8@gmail.com Tabriz University of Medical Sciences scientific Mojgan Mirghafourvand
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3475 1708 mirghafourvand@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women with vulnerable conditions (violence or poverty or unplanned pregnancy). Gestational age 12-14 weeks Possibility of participants attending (depending on location) in antenatal and postnatal group sessions at health centers. Nulliparous women or with a history of vaginal delivery Possibility of access to a smartphone Literacy (at least fifth grade education) Willingness to give birth in Bonab city no limit no limit Female Multiple pregnancy History of cesarean delivery Major fetal anomalies Medical comorbidities History of high-risk pregnancy (stillbirth, recurrent miscarriage, preeclampsia, etc.) Treatment - Other Treatment - Other Intervention group: Participants in the intervention group will receive continuous midwifery care from the 14th week of pregnancy until 6 weeks after delivery by a permanent midwife (researcher). In addition to routine prenatal and postpartum services, this care will include continuous and individualized care in three stages: antenatal (pregnancy), labor, and postpartum. In the prenatal stage, obstetric care will include continuous visits, group education, assessment of the mother's clinical condition, and continuous response to women's physical and psychological needs. For this purpose, six group sessions will be held during pregnancy at intervals of (14-16 weeks, 18-20 weeks, 22-24 weeks, 26-30 weeks, 32-34 weeks, and 36-38 weeks) in health centers in Bonab city. In the postpartum phase, two counseling and education sessions will be held in the health centers of Bonab city within 3 to 5 days and 4 to 6 weeks after delivery. Each group session will be held for 2 hours with the presence of 2 to 10 women and will be facilitated by a researcher (midwifery doctoral student). The content of each session will be based on the educational curriculum of the World Health Organization (WHO), the International Confederation of Midwives (ICM), the national guide to providing midwifery and childbirth services, and the content of the Midwifery continuous care model. The opinions of experts (perinatologists, reproductive health specialists, and midwives) will be used to confirm the content of the sessions. The duration of training in each session will be 60 minutes on predetermined topics focused on the patient's needs and related to the content, and 30 minutes will be allocated to measuring vital signs, listening to the fetal heartbeat, checking the height of the uterus and the weight of the pregnant mother, and the remaining 30 minutes of each session will be allocated to group discussion on possible questions and problems of the mothers. Also, a group will be formed on the social network that the mothers have the most convenient and most access to (such as ETA or WhatsApp, etc.), and the meeting materials will be uploaded there in a completely simple and understandable language, as well as additional materials, and the group members will also have the opportunity to ask questions and answer questions, and the research midwife will be available to the mothers at any time. The control group will receive standard care according to national guidelines. Participants in the intervention group will be encouraged not to visit the hospital before the onset of real pain (even before the start of the active phase of labor, if possible) to minimize unnecessary intervention, and participants will also be emphasized to inform the researcher when they visit and are hospitalized for delivery. For participants in the intervention group, the researcher will be present at their bedside in the labor ward and will support and encourage them throughout all stages of labor (this support includes providing a calm and stress-free environment, psychological and emotional support, and the active presence of the midwife to guide the mother by teaching breathing and relaxation techniques, encouraging the mother to focus on her abilities, reducing anxiety and boosting self-confidence, and helping to do appropriate exercises such as waist movements, kicking mud, and climbing stairs). The mother will be delivered by the researcher's midwife. She will also accompany the mothers in starting breastfeeding for the first 2 hours after delivery to support this stage. If mothers are hospitalized prematurely, the researcher will meet with the mothers in person at least once a day to check on their condition. Participants in both groups will be followed up for up to 6 weeks postpartum, and the final two counseling and education sessions will be held 3-5 days and 4-6 weeks postpartum. Control group: The control group will receive standard care according to national guidelines. Mean score of pregnancy experience. Timepoint: At 34–36 weeks of gestation. Method of measurement: Pregnancy Experience Scale (PES). Mean score of childbirth experience. Timepoint: At 4–6 weeks postpartum. Method of measurement: Childbirth experience questionnaire version 2.0 (CEQ2.0):. Depression scores at both time points, while controlling for baseline levels. Timepoint: At 34-36 weeks of pregnancy and 4-6 weeks after delivery. Method of measurement: Edinburgh postnatal depression scale (EPDS). Frequency of type of delivery (cesarean section and vaginal delivery). Timepoint: After birth. Method of measurement: Maternal and neonatal outcome checklist. Average length of labor stages (active, second, and third phases). Timepoint: In labour. Method of measurement: Maternal and neonatal outcome checklist. Average length of hospitalization until delivery. Timepoint: From hospitalization to delivery. Method of measurement: Maternal and neonatal outcome checklist. Average score of satisfaction with care. Timepoint: After completing the intervention in 36-39 weeks of pregnancy. Method of measurement: Visual Analogue Scale. Average lactation performance score. Timepoint: At 4-6 weeks postpartum. Method of measurement: Breastfeeding performance questionnaire. Average score of fear of childbirth. Timepoint: After birth. Method of measurement: (W-DEQ= The Wijma Delivery Experience Questionnaire version B). Average specific anxiety score. Timepoint: At 4-6 weeks postpartum. Method of measurement: Postpartum specific anxiety scale. Frequency of desire to have more children. Timepoint: At 4-6 weeks postpartum. Method of measurement: Maternal and neonatal outcome checklist. Tabriz University of Medical Sciences Approved 2025-07-30 Ethics Committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)